D-107-2013 Class II Terminated
FDA drug recall D-107-2013 was initiated by Abbott Laboratories on Dec 4, 2012 and is designated Class II. Reason for recall: Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets. The recall status is terminated (terminated Jul 10, 2015). Affected quantity: 28, 524 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 9, 2013
- Initiation Date
- Dec 4, 2012
- Termination Date
- Jul 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28, 524 bottles
Product Description
Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A.
Reason for Recall
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Distribution Pattern
US Nationwide and Puerto Rico
Code Information
LOT # 18262A8 Exp. 09/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-107-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026